783 F. Supp. 2d 236
D. Mass.2011Background
- Plaintiff Louis Kerlinsky, pro se, sues Sandoz and USDVA in a Massachusetts federal court for injuries allegedly from Terazosin HCL prescribed by USDVA.
- The remaining counts are breach of warranty and negligent failure to warn against Sandoz and negligent failure to obtain informed consent against USDVA.
- Terazosin HCL was prescribed by USDVA to treat hypertension and enlarged prostate; warnings on literature mentioned dizziness risk, while vial warnings allegedly stated only ‘May cause drowsiness.’
- Plaintiff alleges a Sept. 1, 2006 adverse event (syncope and cardiac/respiratory issues) after taking Terazosin; hospitalization followed, costs exceeded $41,000; a pacemaker was contemplated but not ultimately needed.
- Plaintiff’s sole expert, Dr. Susan Kerlinsky, offered a supplemental report late in 2010; defendants moved to strike for Rule 26(a)(2)(B) noncompliance; the court later granted motions to strike and granted summary judgment on causation.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Dr. Kerlinsky’s supplemental report complies with Rule 26(a)(2)(B). | Kerlinsky’s report provides causation opinions and mentions data; completeness is sufficient. | Report is vague, lists no data, and lacks qualifications; fails to provide basis for opinions. | Dr. Kerlinsky’s report is deficient and shall be struck. |
| Whether without the expert, plaintiff can prove causation. | Requires expert testimony to establish causation. | Causation cannot be proven without expert testimony; summary judgment warranted. | Summary judgment granted for causation. |
| Whether summary judgment is appropriate on Counts 1, 2, and 6 if expert is stricken. | Still raises issues of design or warning; need evidentiary aid. | Without expert, no proof of causation or informed consent; dismissal appropriate. | Summary judgment for defendants on remaining counts. |
| Whether USDVA’s and Sandoz’s motions to strike expert disclosures should be granted. | Disclosures comply with Rule 26 and should be allowed. | Disclosures fail to meet Rule 26; strike warranted. | Motions to strike granted. |
| Whether Sandoz’s judgment on the pleadings is moot. | N/A | Case resolves via summary judgment; pleadings issue moot. | Denied as moot. |
Key Cases Cited
- In re Neurontin Mktg., Sales Practices, and Prods. Liab. Lit., 612 F.Supp.2d 116 (D. Mass. 2009) (two causation questions in pharmaceutical cases)
- Santiago-Diaz v. Laboratorio Clinico Y De Referencia Del Este, 456 F.3d 272 (1st Cir. 2006) (expert testimony required for medical causation)
- Hayes v. Ariens Co., 391 Mass. 407, 462 N.E.2d 273 (Mass. 1984) (analysis of duty to warn and informed consent)
- Harnish v. Children’s Hosp. Med. Ctr., 387 Mass. 152, 439 N.E.2d 240 (Mass. 1982) (professional expertise required to prove informed consent)
- Adams v. J. Meyers Builders, Inc., 671 F.Supp.2d 262 (D. N.H. 2009) (expert disclosures must adequately describe qualifications and basis)
- Canavan v. Bayer Corp., 432 Mass. 304, 733 N.E.2d 1042 (Mass. 2000) (medical causation requires expert testimony)